Upfront Chemotherapy With Radiation Therapy (CRT) Followed by Chemotherapy in Localized Esophageal Adenocarcinoma

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07603375
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin) — DRUG
    Modified-FOLFOX-6 or FLOT (Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel)

Study Details

The goal of this trial is to learn if adding consolidative chemotherapy to routine chemoradiation can better control both local recurrence and metastasis and reduce the need for surgical intervention.

Key Dates

Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Aug 1, 2029
Completion
Feb 28, 2034

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoradiation with consolidative chemotherapy
    Participants will receive a standard course of chemoradiation followed by consolidative chemotherapy (FOLFOX regimen at the treating physician's discretion).

Primary Outcome Measure

Number of participants with Clinical complete response (cCR) [ Time Frame: approximately 36 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Kaitlin Bailey, RN BSN OCN
919-668-3726
Manisha Palta, MD (PRINCIPAL_INVESTIGATOR)

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